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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON INC BLADDERSCAN SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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VERATHON INC BLADDERSCAN SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number BVI 9400
Device Problem Failure to Charge (1085)
Patient Problem Insufficient Information (4580)
Event Date 01/13/2021
Event Type  malfunction  
Event Description
Bvi 9400 bladder scanner battery chargers intermittently fail to charge batteries due to an apparent manufacturing problem. This issue is experienced pervasively across our hospital and results in delays in providing care and unnecessary catheterizations for patients who could not receive a bladder scan in a timely manner. Manufacturer response for bladder scanner, bvi 9400 (per site reporter). They deny there is a problem.
 
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Brand NameBLADDERSCAN
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
VERATHON INC
20001 north creek pkwy
bothell WA 98011
MDR Report Key11258058
MDR Text Key229618834
Report Number11258058
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBVI 9400
Device Catalogue NumberU270-0404
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2021
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer02/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/01/2021 Patient Sequence Number: 1
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